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Sequent Extended Study

Sequent Extended Study

Recruiting
18 years and older
All
Phase N/A
  • Technical (Original)
  • Simplified (AI rewritten)

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Overview

Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Sequent Please Neo to meet EU Medical Device regulation (MDR) requirements in all the consecutive patients treated with Sequent Please Neo.

Description

The objective of this multicenter, prospective, non-randomized, postmarket clinical follow-up(PMCF) study is to confirm and support the clinical safety and performance of the Sequent Please Neo in a NON-SELECTED, Real Word population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device Regulation requirements for post-market clinical follow-up.

Eligibility

Inclusion Criteria:

  • Patients treated with Sequent please neo according to routine hospital practice and following instruction for use.
  • Informed Consent Signed.

Exclusion Criteria:

  • Patient life expectancy less than 12 months.
  • Contraindication for antiplatelet therapy.
  • Not meet inclusion criteria.

Study details
    Coronary Artery Disease
    Ischemic Heart Disease

NCT05788432

Fundación EPIC

29 July 2025

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